ior EPOCIM ® in the management of anemia of the preterm infant.Phase IV.

• Register: RPCEC
• Last refreshed on: 29 April 2013
• Main ID: RPCEC00000149
• Date of registration: 26/02/2013
• Primary sponsor: Center of Molecular Immunology(CIM)
• Public title: ior EPOCIM ® in the management of anemia of the preterm infant.Phase IV.
• Scientific title: Evaluation of the safety and effectiveness of ior EPOCIM ® in the management of anemia of the preterm infant.
• Date of first enrolment: 16/01/2013
• Target sample size: 121
• Recruitment status: Active
• URL: http://registroclinico.sld.cu/trials/RPCEC00000149-En
• Study type: Interventional
• Study design: Randomization: N/A: single arm study. Blinding: Open. Placebo: Uncontrolled Assignment: Single Group Purpose: Treatment

Countries of recruitment

Cuba

Contacts

• Name: Dra.Giselle Sáurez Martínez
• Affiliation: CIMAB SA

• Name: Dra.Giselle Sáurez Martínez
• Affiliation: CIMAB SA

Key inclusion & exclusion criteria

Inclusion criteria: 1.Preterm patients with weight = 1500 g and gestational age < 34 weeks (determined by the method of date of last menstruation. 2.Patients whose parent or responsible family member has granted your consent to participation in the study in writing. 3.Patients with more than 15 days old. 4.Patients with an intake of at least 50 mL/kg/day of maternal and/or artificial milk.
Exclusion criteria: 1.Patients with diagnosis of hemorrhagic or hemolytic disease. 2.Patients with a diagnosis of major congenital malformation requiring transfer to another service of Neonatology.

Age minimum: 16 days
Age maximum: N/A (No limit)
Gender: Both

Health Condition(s) or Problem(s) studied

Anemia of prematurity

Intervention(s)

Treatment: ior® EPOCIM+ Vitamin+ Ferrous fumarate. ior® EPOCIM: Dose:900 IU/kg body weight/week,3 times per week,300 IU/kg in each administration by subcutaneous route (in the region of the deltoid muscle) to reach the minimum weight established (2500 g),from this moment the administration will be on an outpatient basis up to 40 weeks of corrected gestational age. Vitamin: By oral route from 5 days of life, during all the time of treatment - Vitamin E (25 mg) - Vitamin C (20-60 mg) - Folic acid (1 mg) - Multivitamin complex 10 drops Ferrous fumarate: 2 - 4 mg/kg of weight per day valuing an increase up to 6 mg/kg/day, to increase the oral tolerance, that is, until the newborn receives a contribution of 100 mL/kg/day of maternal and/or artificial milk.

Primary Outcome(s)

Adverse Events (AE) related to the administration of ior ® EPOCIM with causal relationship (Probable or very Probable). Measurement time: 24 months - Occurrence of any AE (Yes, No) - Description of the AE (name of the event) - Duration of the AE ( it will be evaluated by the difference in dates between the start and the completion of the AE) - Intensity of the AE (1. Mild, 2.Moderate, 3.Severe) - Severity of the AE (Severe/serious or Not Severe /Non Serious) - Attitude towards treatment in study (no change, modification of dose, temporary or definitive interruption of treatment in study) - Result of the AE (recovered, improved, squeals, persists or death) - Causality relationship (1.Very likely, 2.Probable, 3.Possible, 4.Unlikely, 5.Unrelated, 6.Not valuable)

Secondary Outcome(s)

Transfusion requirements (Yes, No). Measurement time: 24 months. Number of transfusions required (total of transfusions). Measurement time: 24 months. Hemoglobin (in g/l). Measurement time: initial evaluation (at the time of inclusion), 30 days, 40 a week corrected gestational age, a month after completed the treatment, and 3 Months, 6 months, 9 months, 12 months and the 18th months of corrected gestational age. Hematocrit (in %). Measurement time: initial evaluation (at the time of inclusion), 30 days, 40 a week corrected gestational age, a month after completed the treatment, and 3 Months, 6 months, 9 months, 12 months and the 18th months of corrected gestational age. Volume of blood transfused (in mL). Measurement time:24 months. Neurodevelopmental assessment (Test of Amiel-Tison). Measurement time: after 3 months of corrected gestational age, with a quarterly frequency up to 12 months of corrected gestational age and then to 18 months of corrected gestational age. Evaluation of mental and motor development (Bayley scale). Measurement time: 6 months, 12 months and 18 months of life. Presence of retinopathy (Yes, No. It will be evaluated by Oftalmological exam). Measurement time: between 3 and 6 months of corrected gestational age. Presence of auditory deficit (Yes, No. It will be evaluated by Brain stem auditory evoked potentials in the institution that possible). Measurement time: 3 months of corrected gestational age. Electroencephalogram and visual evoked potential. Measurement time: 3 months of corrected gestational age.

Secondary ID(s)

M9/CIMAB/AEC-2

Source(s) of Monetary Support

Ministry of Public Health(MINSAP)

Secondary Sponsor(s)

Not applicable